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Phase II/III of Recombinant Human Serum Albumin

NCT05858853 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-03-10

No results posted yet for this study

Summary

This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients.

Conditions

  • Cirrhotic Ascites

Interventions

DRUG

Recombinant Human Serum Albumin

The experimental drug (recombinant human serum albumin injection) was administered 10 g/ day for 14 days

DRUG

Recombinant Human Serum Albumin

The experimental drug (recombinant human serum albumin injection) was administered 20 g/ day for 7 days

DRUG

Human serum albumin

Control drug (human blood albumin injection) 10 g/ day for 14 days

DRUG

Human serum albumin

Control drug (human blood albumin injection) 20 g/ day for 7 days

Sponsors & Collaborators

  • Protgen Ltd

    lead INDUSTRY

Principal Investigators

  • Jidong Jia, Ph.D · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2023-09-15
Completion
2023-09-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05858853 on ClinicalTrials.gov